Last Updated on September 28, 2023

Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to the pharmaceuticals products.

1. Drug Manufacturing License

Guidance on Establishment of Pharmaceutical Unit, Application Process for Drug Manufacturing License and Post License Changes
English ( 591 KB – PDF)

2. Drug Registration

Guidance Document For Submission Of Application On FORM 5-F (CTD) For Registration Of Pharmaceutical Drug Products For Human Use .
English ( 444 KB – PDF)

Guidance on Preparation of Summary of Product Characteristics (SmPC)
English ( 386 KB – PDF)

Frequently asked questions about Form 5F (Common Technical Documents)
English ( 256 KB – PDF)

3. Post Approval Variations of Drugs

Post Registration Variation Guidelines For Pharmaceutical and Biological Products
English ( 735 KB – PDF)

4. Non Routine Registration pathways for Drug Registration

Priority Review and Accelerated Approval of Registration / Market Authorization
English ( 426 KB – PDF)

5. Reliance Mechanism

Reliance Mechanism in Regulatory processes, A DRAP’s approach on Good Reliance Practices
English ( 454 KB – PDF)

6. Appeals Against Regulatory Decisions

Guidelines for Filling an Appeal Against the Decisions of Statutory Bodies (e.g. Registration Board)
English ( 371 KB – PDF)